Back to resultsEfficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
Primary Purpose
Post-herpetic Neuralgia
Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
CNV2197944
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-herpetic Neuralgia
Eligibility Criteria
Inclusion Criteria:
Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.
Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.
Exclusion Criteria:
Patients having other severe pain, which may impair the self-assessment of the pain due to PHN.
Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin.
Patients taking more than one medication to treat the PHN pain
Sites / Locations
- Christiaan Barnard Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CNV2197944
Placebo
Arm Description
CNV2197944 75mg tid 21 days
Placebo tid 21 days
Outcomes
Primary Outcome Measures
Pain Intensity Numerical Rating Scale
Secondary Outcome Measures
Pain responder rates
Neuropathic Pain Symptom Inventory
Full Information
NCT ID
NCT01848730
First Posted
May 3, 2013
Last Updated
October 29, 2014
Sponsor
Convergence Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01848730
Brief Title
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
Official Title
A Randomised Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in Patients With Post-herpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Convergence Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.
Detailed Description
A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-herpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNV2197944
Arm Type
Experimental
Arm Description
CNV2197944 75mg tid 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tid 21 days
Intervention Type
Drug
Intervention Name(s)
CNV2197944
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain Intensity Numerical Rating Scale
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Pain responder rates
Time Frame
21 days
Title
Neuropathic Pain Symptom Inventory
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.
Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.
Exclusion Criteria:
Patients having other severe pain, which may impair the self-assessment of the pain due to PHN.
Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin.
Patients taking more than one medication to treat the PHN pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton Raff, MD
Organizational Affiliation
Christiaan Barnard Memorial Hospital, Cape Town, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiaan Barnard Memorial Hospital
City
Cape Town
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia
We'll reach out to this number within 24 hrs